Song Joon Young, Jeong Hye Won, Yun Jong Woo, Lee Jacob, Woo Heung Jeong, Bae Joon-Yong, Park Man-Seong, Choi Won Suk, Park Dae Won, Noh Ji Yun, Cheong Hee Jin, Kim Woo Joo
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Division of Infectious Diseases, Chungbuk National University College of Medicine, Cheongju, Chungcheongbuk-do, Republic of Korea.
Vaccine. 2020 Nov 25;38(50):8016-8023. doi: 10.1016/j.vaccine.2020.10.035. Epub 2020 Oct 31.
Hemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries. This study aimed to evaluate the immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax®) with a 3 + 1 vaccination schedule.
A phase III, multi-center clinical trial was conducted to evaluate the immunogenicity and safety of Hantavax® (three primary doses and a booster dose schedule at 0, 1, 2 and 13 months) among healthy adults. Immune responses were assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Systemic and local adverse events were assessed.
A total of 320 healthy subjects aged ≥19 years were enrolled. Following three primary doses of Hantavax®, the seroconversion rate was 80.97% and 92.81% by PRNT and IFA, respectively. With booster administration, seropositive rates were 67.47% and 95.68% at one-month post-vaccination according to PRNT and IFA, respectively. Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses. Both local and systemic adverse events did not increase with repeated vaccinations.
Hantavax® showed a high seroconversion rate after the three-dose priming, and additional dose administration with 11-month interval induced good booster effects. (ClinicalTrials.gov Identifier: NCT02553837).
肾综合征出血热在欧亚国家是一个严重的健康问题。本研究旨在评估采用3 + 1接种程序的福尔马林灭活汉坦病毒疫苗（汉坦疫苗®）的免疫原性和安全性。
开展了一项III期多中心临床试验，以评估汉坦疫苗®（在0、1、2和13个月时接种三剂主要疫苗和一剂加强疫苗）在健康成年人中的免疫原性和安全性。使用蚀斑减少中和抗体试验（PRNT）和免疫荧光抗体测定（IFA）评估免疫反应。评估全身和局部不良事件。
共纳入320名年龄≥19岁的健康受试者。接种三剂主要的汉坦疫苗®后，PRNT和IFA的血清转化率分别为80.97%和92.81%。加强接种后，根据PRNT和IFA，接种疫苗后1个月时的血清阳性率分别为67.47%和95.68%。在接种三剂主要疫苗期间报告的预期局部和全身不良事件分别为30.50 - 42.81%和16.67 - 33.75%，而在加强接种后报告的分别为36.57%和21.36%。局部和全身不良事件均未随重复接种而增加。
汉坦疫苗®在三剂基础免疫后显示出高血清转化率，间隔11个月接种额外剂量可诱导良好的加强效果。（ClinicalTrials.gov标识符：NCT02553837）
